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NATIONAL ENVIRONMENTAL POLICY ACT DECISION

AND

FINDING OF NO SIGNIFICANT IMPACT

Pioneer Hi-Bred International

High Oleic Soybean

DP-305432-1

United States Department of Agriculture

Animal and Plant Health Inspection Service

Biotechnology Regulatory Services

United States Department of Agriculture (USDA) and the Animal and Plant Health 

Inspection Service (APHIS), have developed a decision document to comply with the 

requirements of the National Environmental Policy Act of 1969, as amended, the Council 

of Environmental Quality’s (CEQ) regulations implementing NEPA, and the USDA and 

APHIS’ NEPA implementing regulations and procedures. This NEPA decision 

document is intended to state APHIS’ NEPA decision and present the rationale for its 

selection.

In accordance with APHIS procedures implementing the NEPA Regulations (7 CFR part 

372), APHIS has prepared an Environmental Assessment (EA) to evaluate and determine 

if there are any potentially significant impacts to the human environment from a 

determination on the regulated status of a petition request (APHIS number 06-354-01p) 

by Pioneer HiBred International, Inc. for DP-305423-1 (hereafter referred to as Pioneer 

305423 soybean). This Glycine max (soybean) variety was genetically engineered to 

produce increased amounts of monounsaturated fatty acid (oleic) and decreased amounts 

of polyunsaturated fatty acids (linoleic and linolenic) and to lesser extent, decreased 

saturated fatty acid (palmitic acid). Pioneer 305423 contains the gm-fad2-1 gene that is 

responsible for the unique oil profile. Pioneer 305423 also expresses a second gene, gmhra, conferring tolerance to sulfonylurea herbicides which was used as a selective agent 

following transformation. APHIS has evaluated the plant pest risks posed by the 

production of Pioneer 305423 and prepared an EA to identify and evaluate any 

environmental impacts resulting from the approval of the petition for nonregulated status. 

The EA assesses alternatives to granting nonregulated status to Pioneer 305423 and 

analyzes the potential environmental and social effects that result from the proposed 

action and the alternatives. The proposed action of USDA APHIS, Biotechnology 

Regulatory Services (BRS) is to grant nonregulated status to Pioneer 305423 and remove 

this GE soybean variety from APHIS’ regulatory oversight in accordance with 7 CFR 

part 340. Comments from the public involvement process were reviewed for substantive 

issues which were considered in developing this NEPA decision. 

In 1986, the Federal Government’s Office of Science and Technology Policy (OSTP) 

published a policy document known as the Coordinated Framework for the Regulation of 

Biotechnology. This document specifies three Federal agencies that are responsible for 
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regulating biotechnology in the United States: USDA-APHIS, the U.S. Department of 

Health and Human Services’ Food and Drug Administration (FDA), and the 

Environmental Protection Agency (EPA). Products are regulated according to their 

intended use and some products are regulated by more than one agency. USDA-APHIS, 

FDA, and EPA enforce agency-specific regulations on products of biotechnology that are 

based on the specific nature of each GE organism. Together, these agencies ensure that 

the products of modern biotechnology are safe to grow, safe to eat, and safe for the 

environment. 

APHIS regulates GE organisms under the Plant Protection Act of 2000. USDA APHISBRS’ mission is to protect America’s agriculture and environment using a dynamic and 

science-based regulatory framework that allows for the safe development and use of GE 

organisms. APHIS regulations at 7 CFR part 340, which were promulgated pursuant to 

authority granted by the Plant Protection Act, as amended (7 United States Code (U.S.C.) 

7701–7772), regulate the introduction (importation, interstate movement, or release into 

the environment) of certain GE organisms and products. A GE organism is considered a 

regulated article if the donor organism, recipient organism, vector, or vector agent used in 

engineering the organism belongs to one of the taxa listed in the regulation (7 CFR § 

340.2) and is also considered a plant pest. A GE organism is also regulated under part 

340 when APHIS has reason to believe that the GE organism may be a plant pest or 

APHIS does not have sufficient information to determine if the GE organism is unlikely 

to pose a plant pest risk.

A person may petition the agency to evaluate submitted data and determine that a 

particular regulated article is unlikely to pose a plant pest risk, and, therefore, should no 

longer be regulated, under 7 CFR § 340.6 “Petition for Determination of Nonregulated 

Status.” The petitioner is required to provide information (§ 340.6(c)(4)) related to plant 

pest risk that the agency uses to determine whether the regulated article is unlikely to 

present a greater plant pest risk than the unmodified organism. After receipt of a petition, 

as per the requirements of § 340.6, BRS makes a determination on whether an organism 

is not likely to pose a plant pest risk and is therefore no longer subject to the regulatory 

requirements of 7 CFR part 340. A GE organism is no longer subject to the regulatory 

requirements of 7 CFR part 340 when APHIS determines that it is not likely to pose a 

plant pest risk.

FDA regulates under the authority of the Federal Food, Drug, and Cosmetic Act. The 

FDA policy statement concerning regulation of products derived from new plant 

varieties, including those genetically engineered, was published in the Federal Register 

on May 29, 1992 (57 FR 22984-23005). Under this policy, FDA uses what is termed a 

consultation process to ensure that human food and animal feed safety issues or other 

regulatory issues (e.g., labeling) are resolved prior to commercial distribution of 

bioengineered food. The EPA regulates plant-incorporated protectants under the Federal 

Insecticide, Fungicide, and Rodenticide Act (FIFRA) and certain biological control 

organisms under the Toxic Substances Control Act (TSCA). 
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Pioneer 305423 soybean has successfully completed the consultation process with the 

FDA concerning food and feed safety (BNF No. 000110). FDA has no more questions 

on nutritional or safety issues, and has provided a summary response indicating that “the 

food and feed derived from the 305423 soybean are as safe and nutritious as food and 

feed derived from conventional soybean varieties currently being marketed.” Because 

Pioneer 305423 soybean does not contain any genetically engineered pesticides or 

tolerance to herbicides, EPA consultation is not required.

Document History

On December 20, 2006 APHIS BRS received a petition from Pioneer HiBred 

International seeking a determination of nonregulated status for DP-305423 soybean. A 

revised version of the petition was received on October 10, 2007. Upon receipt of the 

petition, BRS reviewed the information submitted and deemed the petition complete on 

October 22, 2007. Based upon information provided in the petition, BRS prepared a draft 

EA and Plant Pest Risk Assessment (PPRA) (USDA-APHIS 2009). 

Public Involvement

On September 2, 2009, APHIS published a notice in the Federal Register (74 FR 45413-

45415, Docket no. 2007-0156) announcing the availability of the Pioneer petition 

requesting non regulated status for 305423 soybean, a draft plant pest risk assessment and 

a draft EA for a 60 day public comment period. Because the original docket was not the 

authorized APHIS version, a subsequent 60 day comment period was published on 

October 26, 2009 in the Federal Register (74 FR 54950-54951, Docket no. 2007-0156) 

announcing the availability of the corrected EA. This comment period ended on 

December 28, 2009. In total, 40 comments were received from the public during the two 

comment periods. All comments were analyzed to identify new issues, alternatives, or 

information. Responses to the substantive comments are attached to the docket submitted 

to the Federal Register with this Finding of No Significant Impact.

Major Issues Addressed in the EA

The EA describes the alternatives considered and evaluated using the identified issues. 

Issues considered in the EA were developed based on APHIS’ determination to grant 

nonregulated status for certain genetically engineered organisms and for this particular 

EA, the specific deregulation of Pioneer Event DP-305423 for production of high oleic 

fatty acid. The following issues were identified as important to the scope of the analysis 

(40 CFR 1508.25): 

Soybean

• Gene Movement (Pollen Flow)

• Weediness

• Human Health

• Animal Feed

Agricultural Production of Soybean

• Growing Regions and Acreage

• Organic and Conventional Soybean Production

• Herbicide Use
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Soybean Composition

• Oil Composition

• Soybean Meal Composition

• Proximate, Isoflavones and Antinutrients

Impacts on Non-target Organisms

• Toxicity and Allergencity

• Nutrition

• Pest and Disease

• Soil Communities

• Threatened and Endangered Species

Affected Environment: 

Although the preferred alternative would allow for plantings of Pioneer 305423 soybean

to occur anywhere in the U.S., APHIS limited the environmental analysis to those areas 

that currently support soybean production. To determine areas of soybean production, 

APHIS used data from the National Agricultural Statistics Service (NASS) 2002 Census 

of Agriculture to determine where soybean is produced in the United States 

(www.nass.usda.gov, accessed 2/19/2010). Only 17 states in 2008 produced more than 1 

million acres among the 31 that produced soybean according to the 2002 Census of 

Agriculture. Because the oil derived from this Pioneer 305423 soybean will likely 

replace that from existing soybean varieties, it is not likely that new land beyond that 

currently or historically used for soybean production will be planted to soybean by 

growers. 

Alternatives that were fully analyzed:

The EA analyzes the potential environmental consequences of a proposal to grant 

nonregulated status to 305423 soybean. In order for 305423 soybean to be granted 

nonregulated status, APHIS must determine that 305423 soybean is not likely to pose a 

plant pest risk. The analysis provided in the plant pest risk assessment (USDA-APHIS 

2009) demonstrates that there is sufficient data to determine that 305423 soybean is not 

likely to pose a plant pest risk and therefore is eligible for nonregulated status.

The regulations at 7 CFR 340.6(d)(3)(i) state that APHIS may "approve the petition in 

whole or in part." Because APHIS has found that 305423 soybean is not likely to pose a 

plant pest risk, the only alternative considered in the EA is granting nonregulated status 

“in whole” to 305423 soybean. An “in part” deregulation can be given if there is a plant 

pest risk associated with some, but not all lines requested in a petition. The petition for 

Pioneer 305423 soybean only requested APHIS to grant nonregulated status to one 

soybean event, therefore, an “in part” determination is not an appropriate consideration. 

Thus, there are two alternatives that are considered in this EA: (1) no action and (2) to 

grant nonregulated status to 305423 soybean, “in whole.”

Alternative A. No Action: Continuation as a Regulated Article

Under the "no action" alternative, APHIS would deny the petition. Pioneer 305423 

soybeans and progeny derived from them would continue to be regulated articles under 
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the regulations at 7 CFR part 340. Permits issued or notifications acknowledged by 

APHIS would still be required for introductions of Pioneer 305423 soybeans and 

measures to ensure physical and reproductive confinement would continue to be 

implemented. APHIS might choose this alternative if there were insufficient evidence to 

demonstrate the lack of plant pest risk from the unconfined cultivation of Pioneer 305423 

soybeans. 

Soybean breeders have achieved soybean oil compositional changes by both conventional 

breeding and genetic engineering (Fehr 2007). Under this no action alternative, growers 

and other parties who are involved in production, handling, processing or consumption of 

soybean would continue to have access to existing deregulated GE high oleic acid 

soybean products as well as conventional high or mid level oleic soybean varieties. 

However, growers would not have widespread access to soybean varieties based on 

Pioneer 305423 soybean since it would continue to be regulated under Part 340. There is 

no potential for human consumption of Pioneer 305423 soybean high oleic acid soybean 

under this alternative. 

This alternative is not the preferred alternative because APHIS has already determined 

through a plant pest risk assessment (USDA-APHIS, 2009) that Pioneer 305423 soybean 

is unlikely to pose a plant pest risk. Choosing this alternative would hinder the purpose 

and need of APHIS to allow for the safe development and use of GE organisms given that 

Pioneer 305423 soybean is unlikely to pose a plant pest risk.

Alternative B. Preferred Alternative: Grant nonregulated status to Pioneer 305423 

soybean, “in whole”- Preferred Alternative: Determination that Pioneer 305423 

soybean is no longer a regulated article.

Under this alternative, Pioneer 305423 soybeans and progeny derived from them would 

no longer be regulated articles under the regulations at 7 CFR part 340. Pioneer 305423 

soybean is eligible for nonregulated status because APHIS has determined that this GE 

organism is unlikely to pose a plant pest risk (USDA-APHIS 2009). Permits issued or 

notifications acknowledged by APHIS would no longer be required for introductions of 

high oleic acid soybeans derived from this event. APHIS might choose this alternative if 

there was sufficient evidence to demonstrate the lack of plant pest risk from the 

unconfined cultivation of high oleic acid soybeans derived from this event. 

Under this alternative, growers may have future access to Pioneer 305423 soybean and 

progeny derived from this variety if the developer decides to commercialize Pioneer 

305423. In addition, growers and other parties that are involved in production, handling, 

processing or consumption of soybean would continue to be able to use the current high 

or mid level oleic soybean products by conventional breeding as well as the genetically 

engineered soybean variety. Consumers may benefit by having access to a greater range 

of potentially healthful food products. By granting nonregulated status to Pioneer 

305423 soybean, the purpose and need to allow the safe development and use of GE 

organisms is met. 
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APHIS has chosen Alternative B as the preferred alternative for the proposed action

because APHIS has determined that Pioneer 305423 soybean is unlikely to pose a plant 

pest risk (USDA-APHIS 2009). 

Alternatives Considered but Rejected from Further Consideration:

Geographic restrictions -APHIS considered geographic restrictions based upon 

geographic variation in plant pest risk. As presented in APHIS plant pest risk assessment 

for Pioneer 305423 soybean, there is no geographic differences in the plant pest risks for 

Pioneer 305423 soybean (USDA-APHIS 2009). This alternative was rejected and not 

analyzed in detail because Pioneer 305423 soybean is unlikely to pose a plant pest risk 

and therefore, APHIS will have no regulatory authority over Pioneer 305423 soybean and 

will be unable to impose regulatory restrictions on this GE soybean variety.

Environmental Consequences of APHIS’ Selected Action

The EA contains a full analysis of the alternatives to which we refer the reader for 

specific details. The following table briefly summarizes the results for each of the issues 

fully analyzed in the Environmental Consequences section of the EA.

Table 1.

Attribute/Measure Alternative A

No Action

Alternative B

Deregulation in Whole

(Preferred Alternative)

Meets APHIS Purpose and 

Need and Objectives

No Yes

Unlikely to pose a plant pest 

risk

Satisfied through use of 

regulated field trials

Satisfied—risk assessment 

(USDA-APHIS 2009)

Farmer choice Not available commercially No restrictions

Soybean

Gene Movement (Pollen 

Flow)

Minimal Minimal

Weediness None None

Human Health Unchanged Unchanged

Animal Feed Unchanged Unchanged

Agricultural Production of 

Soybean

Growing Region and 

Acreage

Unchanged Unchanged

Organic and Conventional 

Soybean Production

Unchanged Unchanged

Herbicide Use Unchanged Unchanged

Soybean Composition

Oil Composition Unchanged FDA approved safety of 

changes
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Soybean Meal Composition Unchanged Unchanged

Proximate, Isoflavones and 

Antinutrients

Unchanged Unchanged

Impacts on Non Target 

Organisms

Toxicity and Allergenicity Unchanged Unchanged

Nutrition Unchanged Unchanged

Pest and Disease Unchanged Unchanged

Soil Communities Unchanged Unchanged

Threatened and Endangered 

Species

Unchanged Unchanged

Other Regulatory 

Approvals

U. S. Completion of FDA 

consultation

Completion of FDA 

consultation

Foreign Trade Approvals from Canada, 

Mexico

Approvals from Canada, 

Mexico

Compliance with Other 

Laws

CWW, CAA. EOs Fully compliant Fully compliant

Finding of No Significant Impact

The analysis in the EA indicates that there will not be a significant impact, individually or 

cumulatively, on the quality of the human environment as a result of this proposed action. 

I agree with this conclusion and therefore find that an EIS need not be prepared. This 

NEPA determination is based on the following context and intensity factors (40 CFR 

1508.27):

Context – The term “context” recognizes potentially affected resources, as well as the 

location and setting in which the environmental impact would occur. This action has 

potential to affect conventional and organic soybean production systems, including 

surrounding environments and agricultural workers; human food and animal feed 

production systems; and foreign and domestic commodity markets. As identified in the 

Affected Environment section above, although the preferred alternative would allow for 

new plantings of DP-305423 soybean to occur anywhere in the U.S., the environmental 

analysis is limited to those areas that currently support soybean production, 

predominantly focused in 17 states. Users of soybean products, both food and industrial 

products could be potentially impacted by this action. 

Intensity – Intensity is a measure of the degree or severity of an impact based upon the 

ten factors. The following factors were used as a basis for this decision: 

1. Impacts that may be both beneficial and adverse.

The advantageous and healthful properties of oil derived from the DP-305423 

soybean and properties of the fatty acid ratios are in demand by food producers to 

replace to some extent oil products from existing lines of soybean. The 
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commercialization of Pioneer 305423 soybean could be beneficial for the 

consumer’s health. Increased intake of oils high in monounsaturated fatty acids, 

such as oleic acid have been shown to have positive effects on total cholesterol 

levels when compared to equal intakes of hydrogenated oils (Lichtenstein et al. 

2006). Likewise, increased intake of oils high in oleic acid can decrease LDLcholesterol levels compared to equal intakes of saturated oils (Mensink et al. 

1989) and increased HDL-cholesterol levels compared to an equal intake of 

polyunsaturated oil (Mata et al. 1992). Moderate consumption of oil high in oleic 

acid has also demonstrated decreases in systolic blood pressure (Bondia-Pons et 

al. 2006). As identified in the response to comments, concern has been expressed

that if a sufficient amount of Pioneer 305423 soybeans inadvertently enters the 

commodity soybean supply stream and not the appropriate identity preserved food 

chain, the Nutrition Facts Panel of some products may not correctly reflect the 

fatty acid ratios. As described in Chapter 5 of the EA, Pioneer 305423 soybean is 

expected to be adopted as an adjunct to conventional commodity soybean oil, but 

will be marketed as a specialty soybean and grown under an identity preserved 

process thereby reducing the potential of inadvertent mixing. Granting 

nonregulated status to DP 305423 soybean will not impact agricultural acreage 

devoted to soybean production, and will likely only displace production of 

existing varieties. If this line is given non regulated status, there are no 

foreseeable changes to the availability of GE, conventional, organic or specialty 

soybean varieties on the market. 

2. The degree to which the proposed action affects public health or safety.

The proposed action to grant nonregulated status to DP-305423 soybean would 

have no significant impacts on human or animal health. High oleic acid event DP 

305423 is not materially different in composition, safety, or any other relevant 

parameter from soybean now grown, marketed, and consumed, except for the 

desired increases in oleic acid, and decreases in linoleic and linolenic acid.

Information presented in the petition suggests that because alterations of these 

common fatty acids resemble ratios of fatty acids that are derived from other 

oilseed crops, no impacts were expected from the commercial sale or use of the 

derived oils in foods. As described in Chapter 5 of the EA, soybean varieties with 

alterations of fatty acid ratios are currently available to growers, including those 

with elevated oleic acid. These crops have been used safely in the marketplace. 

FDA completed the safety and nutritional assessment for this product and had no 

further questions regarding the safety of Pioneer 305423 soybean (FDA 2009). 

Based on the assessment of the laboratory evidence provided in the petition and 

accompanying scientific literature, APHIS has concluded that Pioneer 305423 

soybean would have no significant impacts on human or animal health.

3. Unique characteristics of the geographic area such as proximity to historic or 

cultural resources, park lands, prime farmlands, wetlands, wild and scenic rivers, 

or ecologically critical areas.

There are no unique characteristics of geographic area such as park lands, prime 

farm lands, wetlands, wild and scenic areas, or ecologically critical areas that 

would be significantly affected. DP-305423 will only be grown in areas suitable 

for the production of soybean and those historically used for soybean production. 
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There is no significant difference in performance or agricultural practices for the 

growth of DP-305423 soybean compared to other soybean varieties, and no 

natural resources or land usage will be significantly altered through the 

production of DP-305423 soybean. 

4. The degree to which the effects on the quality of the human environment are likely 

to be highly controversial.

The effects on the quality of the human environment are not highly controversial. 

Although there is some opposition to the granting of nonregulated status to DP305423 soybean, this action is not highly controversial in terms of size, nature or 

effect. Other than objections to all genetically engineered crops, the public 

comments did not register any specific factual concerns with the data provided 

APHIS for this crop and which were presented in the EA. Interest in maintaining 

product identity and separation was expressed, because some products might be 

affected by differences of DP-305423 soy oil from commodity soy oil. The 

importance of company sponsored stewardship plans and manufacturer 

surveillance of purchased oil is discussed in the APHIS response to comments.

5. The degree to which the possible effects on the human environment are highly 

uncertain or involve unique or unknown risks.

The effects of the proposed non regulated status for DP 305423 are not highly 

uncertain and do not involve unique or unknown risks. Based on the analysis 

documented in the EA, the effects on the human environment would not be 

significant. APHIS has no evidence for any unknown risks of this product when 

released for commercial production. As described in Chapter 5 of the EA and 

response to comments, well established management practices, production 

controls, and production practices (GE, conventional, and organic) are currently 

being used in soybean production systems in the US. Therefore, it is reasonable 

to assume that farmers, who produce conventional soybean, DP-305423 soybean, 

or produce soybean using organic methods, will continue to use these reasonable, 

commonly accepted best management practices for their chosen system and 

varieties during agricultural soybean production. Additionally, most of the 

soybean acreage in the U.S. is planted to GE varieties. Of the total soybean acres 

planted in 2008, 92% were GE glyphosate tolerant soybean varieties (USDANASS 2008). The availability of DP 305423 soybean would offer growers and 

manufacturers another choice of modified fatty acids in addition to the options 

already available. 

6. The degree to which the action may establish a precedent for future actions with 

significant effects or represents a decision in principle about a future 

consideration. 

The proposed action would not establish a precedent for future actions with 

significant effects or represent a decision in principle about a future decision. 

Similar to past petitions for nonregulated status 

(http://www.aphis.usda.gov/brs/not_reg.html), the APHIS decision on the 

regulatory status of DP 305423 soybean will be based upon information provided 

in the applicant submitted petition. APHIS regulations at 7 CFR part 340, 

regulate the introduction (importation, interstate movement, or release into the 

environment) of certain GE organisms and products. A person may petition the 
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agency to evaluate submitted data and determine that a particular regulated article 

is unlikely to pose a plant pest risk, and, therefore, should no longer be regulated, 

under 7 CFR § 340.6 “Petition for Determination of Nonregulated Status.” After 

receipt of a petition, BRS makes an independent determination on whether an 

organism is unlikely to pose a plant pest risk and is therefore no longer subject to 

the regulatory requirements of 7 CFR part 340. Each petition that APHIS 

receives undergoes this independent review to determine if the regulated article 

poses a plant pest risk. 

7. Whether the action is related to other actions with individually insignificant but 

cumulatively significant impacts.

No significant cumulative effects were identified through this assessment. The 

EA discussed cumulative effects on soybean management practices, human and 

animal health, and the environment and concluded that such impacts were not 

significant. A cumulative effects analysis is included in Chapter 5 of the EA. 

8. The degree to which the action may adversely affect districts, sites, highways, 

structures, or objects listed in or eligible for listing in the National Register of 

Historic Places or may cause loss or destruction of significant scientific, cultural, 

or historical resources.

DP 305423 soybean would have no impact on districts, sites, highways, 

structures, or objects listed in or eligible for listing in the National Register of 

Historic Places, nor would they likely cause any loss or destruction of significant 

scientific, cultural, or historical resources. Granting nonregulated status to DP 

305423 soybean will not cause an increase in agricultural acreage devoted to 

soybean cultivation, or to acres devoted to GE soybean cultivation because the 

product oil will replace some existing soybean oil, both conventional commodity 

soybean oil and specialty oils such as low linolenic oil. DP-305423 soybean will 

not alter geographic locations of future soybean production in the U.S. because 

the crop has production needs that are the same as those for conventional soybean.

9. The degree to which the action may adversely affect an endangered or threatened 

species or its habitat that has been determined to be critical under the 

Endangered Species Act of 1973.

APHIS evaluated the potential for negative effects on federal threatened and 

endangered species as listed by the U.S. Fish and Wildlife Service from 

cultivation of 305423 soybean and its progeny and determined that the release of 

305423 soybean, following a determination of nonregulated status, would have no 

effect on federally listed threatened or endangered species or species proposed for 

listing, or on designated critical habitat or habitat proposed for designation (see 

section on Threatened and Endangered Species, pages 25-28 of the EA).

10. Whether the action threatens a violation of Federal, State, or local law or 

requirements imposed for the protection of the environment.

The proposed action would be in compliance with all federal, state, and local 

laws. The proposed action to grant nonregulated status to DP-305423 and remove 

this GE soybean variety from APHIS’ regulatory oversight would be carried out 

in accordance with 7 CFR part 340. DP-305423 soybean has successfully 

completed the consultation process with the FDA concerning food and feed safety 
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(Appendix 1 of the EA). DP-305423 soybean does not express any genetically 

engineered pesticides or tolerance to herbicides; thus EPA consultation is not 

required for this product. There are no other Federal, state, or local permits that 

are needed prior to the implementation of this action. A list of the current status 

of U.S. and international approvals is found in Table 1 of this Decision 

Document.

Literature Cited:

Bondia-Pons, I., Schroeder, H., Covas, M., Castellote, A.I., Kaikkonen, J., Poulsen, H.E., 

gaddi, A.V., Machowetz, A., Kiesewetter, H., and Lopez-Sabater, C. (2006) 

Moderate consumption of olive oil by healthy European men reduces systolic 

blood pressure in non-Mediterranean participants. J. Nutrition 177, 84-87.

FDA (2009) Biotechnology Consultation Note to the file on soybean event 305423 (BNF 

No. 000110). 

http://www.fda.gov/Food/Biotechnology/Submissions/ucm155595.htm. 

(Accessed 6/20/2009).

Lichtenstein, A., Mathan, N.R., Jalbert, S.M., Resteghini, N.A., Schaefer, E.J., and 

Ausman, L.M. (2006) Novel soybean oils with different fatty acid profiles alter 

cardiovascular disease risk factors in moderately hyperlipidemic subjects. Am. J. 

Clin. Nutr. 84:497-504.

Mata, P., Alvarez-Sala, L.A., Rubio, M.J., and Oya, M.D. (1992) effects of long-term 

monounsaturated- vs polyunsaturated-enriched diets on lipoproteins in healthy 

men and women. Am. J. Clin. Nutr. 55:846-850.

Mensink, R.P., and Katan, M.B. (1989) Effect of a diet enriched with monounsaturated or 

polyunsaturated fatty acids on levels of low-density and high density lipoprotein 

cholesterol in healthy women and men. New England Journal of Medicine 321 

No 7.

USDA-APHIS (2009) Plant Pest Risk Analysis for Pioneer 305423 soybean. USDA, 

APHIS, Biotechnology Regulatory Service. Riverdale, MD 

http://www.aphis.usda.gov/brs/not_reg.html

USDA-NASS. (2008) Acreage. United States Department of Agriculture, National 

Agricultural Statistics Service, Washington, D.C.

http://usda.mannlib.cornell.edu/usda/current/Acre/Acre-06-30-2008.txt
NEP A Decision and Rationale 

I have carefully reviewed the EA prepared for this NEP A detennination and the input 

from the public involvement process. I believe that the issues identified in the EA are 

best addressed by selecting Alternative B - Grant nonregulated status to Pioneer 305423 

soybean, "in whole". 

As stated in the CEQ regulations, "the agency's preferred alternative is the alternative 

which the agency believes would fulfill its statutory mission and responsibilities, giving 

consideration to economic, environmental, technical and other factors." The preferred 

alternative has been selected for implementation based on consideration of a number of 

environmental, regulatory, and social factors. Based upon our evaluation and analysis, 

Alternative B is selected because (1) it allows APHIS to fulfill its statutory mission to 

protect America's agriculture and environment using a dynamic and science-based 

regulatory framework that allows for the safe development and use of genetically 

engineered organisms; and (2) it allows APHIS to fulfill its regulatory obligations. Since 

APHIS has concluded that that Pioneer DP 305423 soybean is unlikely to pose a plant 

pest risk, APHIS has no authority to continue to regulate a GE organism once it has 

detennined that the GE organism does not pose a plant pest risk. The comments 

identified from public involvement did not change the results ofthe analysis. Therefore, 

it is my decision to implement the preferred alternative as described in the EA. 

A(J,tU.J~ JUN 7 2010 

fo Michael C. Gregoire Date 

Deputy Administrator 

Biotechnology Regulatory Services 

Animal and Plant Health Inspection Services 

U.S. Department ofAgriculture